Any Product Design Input sample for Colonoscope devices

D

dilemma

Wanna some Product Design Input sample for Colonoscope medical devices.

THANXX
 
J

Julie O

If this is an FDA-regulated device, what is the classification number and/or product code?
 
D

dilemma

If this is an FDA-regulated device, what is the classification number and/or product code?
Thank Julie for your response. It is Class II device.
I recently processing FDA registration of new colonoscope system which required Design Input documents. There are many different requirements from FDA, ISO13485, also from other articles about the titles of requirements should be considered.

I hope there will be some samples (design input of medical devices) for me as references.

Thank you
 
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